Non-steroidal Anti-inflammatory drugs
Ibuprofen 300 mg
20Capsules
CA-07
49/2011
13/2/2011
Mechanism Of Action | Ibuprofen possesses analgesic and antipyretic activities. Its mode of action, like that of other nonsteroidal anti- inflammatory agents, may be related to prostaglandin synthetase inhibition. |
INDICATIONS | KANAPROFEN is indicated for relief of the signs and symptoms of rheumatoid arthritis, back paine, sciatice, and toothaches. KANAPROFEN is indicated for relief of mild to moderate pain. KANAPROFEN is also indicated for the treatment of primary dysmenorrhea |
CONTRAINDICATIONS | KANAPROFEN tablets are contraindicated in patients with known hypersensitivity to Ibuprofen. KANAPROFEN tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe anaphylactic-like reactions to NSAIDs have been reported in such patients. KANAPROFEN tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery, because of increasing incidence of myocardial infarction and stroke. |
Side EFFECTS | The most common side effects from ibuprofen are rash, ringing in the ears, headaches, dizziness, drowsiness, abdominal pain, nausea, diarrhea, constipation and heartburn. Ibuprofen may cause ulceration of the stomach or intestine, and the ulcers may bleed. Sometimes, ulceration and bleeding can occur without abdominal pain, and black tarry stools, weakness, and dizziness upon standing (orthostatic hypotension) may be the only signs of a problem. Elderly patients are at greater risk for serious gastrointestinal events. NSAIDs reduce the flow of blood to the kidneys and impair function of the kidneys. The impairment is most likely to occur in patients with preexisting impairment of kidney function or congestive heart failure, and use of NSAIDs in these patients should be done cautiously. |
WARNINGS | Clinical trials of several COX-2 selective and nonselective NSAIDs have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke. NSAIDs, including ibuprofen, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy. Fluid retention and edema have been observed in some patients taking NSAIDs. KANAPROFEN tablets should be used with caution in patients with fluid retention or heart failure. NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Other factors that increase the risk of GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Therefore, special care should be taken in treating this population with ibuprofen or the other NSAIDs. To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should be used for the shortest possible duration. Treatment with KANAPROFEN is not recommended in patients with advanced renal disease. If KANAPROFEN therapy must be initiated, close monitoring of the patients renal function is advisable. NSAIDs, including ibuprofen, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. |
DRUG INTERACTIONS | Ibuprofen should be avoided in concomitant use with the following: 1- ACE-inhibitors. 2- Aspirin. 3- Furosemide and thiazides. 4- Lithium compounds. 5- Methotrexate. 6- Coumarin-type anticoagulants |
Pregnancy And lactations | In late pregnancy, as with other NSAIDs, ibuprofen should be avoided because it may cause premature closure of the ductus arteriosus. Because many drugs are excreted in human-milk and because of the potential for serious adverse reactions in nursing infants from ibuprofen, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother |
Dosage And Administration | Do not exceed 2400 mg total daily dose. Ibuprofen should be taken with meals. Initially 2 capsules twice daily increasing to 3 twice daily if necessary Maintenance : 1 or 2 capsules twice daily |
OVERDOSE | In cases of acute overdosage, the stomach should be emptied by vomiting or lavage. Because the drug is acidic and is excreted in the urine, it is theoretically beneficial to administer alkali and induce diuresis. In addition to supportive measures, the use of oral activated charcoal may help to reduce the absorption and reabsorption of KANAPROFEN tablets. |
Storage Conditions | “Keep out of reach of children” Store below 30 C |